Services for Importers

For importers, we provide the following services

Pre-Marketing Support

Authorized agent/ registration holder support
We have a valid wholesale license and support our customers by acting as an Authorized Agent or Registration Holder. We help MNCs import and register their products

Market Authorization
We help our clients all the way in the process of Market Authorization

Import License
We assist our clients to get the import license smoothly quickly

Test License
We help prepare the complete documentation for getting the test license in Form-29, Form-30

Self-life Extension
The regulatory team at Reseapro will help you acquire shelf-life extension for your products by filing the required documents with the regulatory authorities to facilitate quick permissions.

Global Regulatory Services:

Compile, review, publish and file regulatory dossier

Manage the submission of dossier

Life cycle management and investigational filing

Compile and publish reports

Develop content and documentation

Pre- and post-registration services

Pre-Registration services

Regulatory and quality compliance services and export report

Conversion of data or document or dossier to country specific or ACT to CTD and vice versa and analysis of gap.

Assessing the documents and existing dossier

Site due diligence for Active Pharmaceutical Ingredients (API) site and Finished Product (FP) site and GMP compliance

Assisting and providing guidance on adequate and relevant data generation for the submission of dossier successfully to country specific regulatory Authorities.

Post- Registration services

We provide post-approval regulatory changes to ourcustomers and assist themin addressing variations (major, minor or critical). We help updateexisting documents as per the country-specific regulatory requirements. We also provide assistance in the extension of labels and shelf-life.